Kinapse Blog
Read our latest insights into the Life Sciences industry.
Kinapse provides expert standalone document quality control services
Back to Kinapse blog Kinapse provides expert standalone document quality control services The number of clinical trials as well as the amount of regulatory documentation [...]
Lessons Learnt from the Presence of N-nitrosamine Impurities in Sartan Medicines
Lessons Learnt from the Presence of N-nitrosamine Impurities in Sartan Medicines In 2018, the European medicines regulatory network became aware of [...]
Overview of the new drug regulation registration (DRR) in China
Overview of the new Drug Regulation Registration (DRR) in China On the 1st July 2020 the new Drug Regulation Registration [...]
Kinapse welcomes you to ICH Q12
Kinapse welcomes you to ICH Q12 Back to Kinapse blog May 2020 The USFDA has recently released [...]
Kinapse welcomes you to ICH Q12
Kinapse welcomes you to ICH Q12 Back to Kinapse blog April 2020 On 9th April 2020, Swissmedic [...]
Kinapse welcomes you to ICH Q12
Back to Kinapse blog March 2020 On 4th March 2020, EMA published adoption of ICH Q12 guideline along with an [...]
Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities
Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities The deadline to respond to EMA Art. 5(3) Referral [...]
Kinapse welcomes you to ICH Q12
Back to Kinapse blog December 2019 Kinapse welcomes you to ICH Q12 The key milestone [...]
Kinapse launches Plain Language Summary Portal
Kinapse launches Plain Language Summary Portal Kinapse, a Syneos Health Company, a market leader in clinical trial disclosure services, announced the launch of ClinTrialDataShare.com, a web portal for sponsors to [...]
Product Acquisition: Acquiring a Portfolio of Marketed Products
Learn why requirements for plain-language summaries of clinical studies, aimed at a broad, non-technical audience, could create new risks for sponsors.
The Regulatory Times – June 2019
Your monthly round-up of international Life Sciences regulatory news from the past month. Follow the link to read June's edition from Kinapse.
The Regulatory Times – May 2019
Your monthly round-up of international Life Sciences regulatory news from the past month. Follow the link to read April's edition from Kinapse.
The Regulatory Times – April 2019
Your monthly round-up of international Life Sciences regulatory news from the past month. Follow the link to read April's edition from Kinapse.
The Regulatory Times – March 2019
Your monthly round-up of international Life Sciences regulatory news from the past month. Follow the link to read March's edition from Kinapse.
Brexit is Approaching: What are the Implications for the EU QPPV?
With the UK set to leave the EU in the near future, Kinapse examines the potential implications for the EU QPPV
The Regulatory Times February 2019
Your monthly round-up of international Life Sciences regulatory news from the past month. Follow the link to read February's edition from Kinapse.
